Microbiome Interactions in Tuberculosis (MERIT)
Pulmonary tuberculosis
This study is a prospective, longitudinal observational study, conducted at Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK. Participants will be recruited from the outpatient and inpatient tuberculosis services at Glenfield Hospital. Both suspected and confirmed TB patients will be recruited. Participants with confirmed pulmonary TB will be followed up along with routine clinical appointments – baseline, 2 weeks, 8 weeks, 16 weeks and 24 weeks after starting anti-TB treatment and at the end of treatment. 6 months and 12 months after the end of treatment visits will be optional. Participants will undergo routine clinical tests such as blood tests, CXR, CT, bronchoscopy and sputum collection as well as research tests such as blood tests, bronchoscopy (if not done as a routine clinical test), bioelectrical impedance analysis (BIA), dual energy x-ray absorptiometry (DEXA), EQ-5D-5L questionnaires, spirometry, and sputum collection. Muscle biopsy, muscle function assessments and physical activity monitoring are optional. Participants who are confirmed not to have tuberculosis following bronchoscopy will continue to undergo the same research procedures as those with confirmed tuberculosis, up to 8 weeks. After that, participants will be discharged from the study and will continue their care through routine clinical services. Clinical protocols of care, including investigations and therapy decisions, will not be influenced in any way by study enrolment.
1. Provision of informed consent 2. Aged 16 years or older 3. Engagement with the Leicester Clinical TB service with either suspected TB or active TB disease
1. Any chronic medical disorder which, in the opinion of the investigator, may either put the subject at risk (because of participating in the study) or may influence the results of the study or the subjects’ ability to participate in the study 2. Donation of blood >450 ml within 3 months of study commencement or during the study (other than for study purposes). 3. Pregnancy or lactation 4. Participation in an interventional clinical study in the 3 months prior to of Visit 1 or participation in a study using interventional medicinal products in the previous 6 months 5. Previous chemotherapy for LTBI in the last 5 years 6. Previous treatment for active TB disease in the last 2 years